In an era where formulation challenges are increasingly common, established, flexible, oral controlled release technologies are important tools for creating approvable, innovative products.
A number of established oral controlled release companies have shifted their investment focus towards product development. Today,
few companies exist
that offer established, flexible, oral controlled release technologies
that resolve product development problems
and result in clinically meaningful products.
Penwest Pharmaceuticals has a suite of established, approved technologies that enable the development of oral-controlled release products. These technologies can be customised to deliver drugs via a wide range of desired release profiles.
| SyncroDose-controlled drug release process. |
 |
| SyncroDose formulations are compressed with TIMERx to prevent premature release in the stomach |
In this example, drug release begins in earnest after 4-5 hours... |
...and continues to deposit drug in |
...distributing drug throughtout the large intestine |
| |
|
|
|
TIMERx®
TIMERx consists of a proprietary blend of materials combined to achieve the desired drug release profile. The technology is not dependent on the acidic environment in the intestinal tract or other factors that can vary greatly between individuals and their diet.
TIMERx is inexpensive, and can be used to create tablets using standard tablet manufacturing equipment and processes. It has been used in approved products worldwide. Its most recent product success was Opana® ER, a sustained release formulation of oxymorphone for the treatment of pain.
CRITICRITICAL PPOIINTSTS TTO CCONSIDERSIDER WWHEEN CCHOOSISINGG A DRDRUGG DEDELIIVERERY PPARTRTNERER
- Is the technology currently in use in an approved product in the US or in Europe?
- Does the technology require special manufacturing or other incremental equipment?
- Are the components of the technology generally regarded as safe?
- Is the technology sufficiently flexible enough to allow the inclusion of other drugs
or ingredients?
- Does the drug delivery partner have a proven track record of product development, from product concept to finished formulation?
|
When some controlled-release formulations are consumed with alcoholic beverages, the formulations can rapidly fall apart, resulting in the drug to be released and absorbed quickly, causing major side effects, such as respiratory depression observed with potent pain medications. TIMERx is not susceptible to this alcohol-induced ‘dose-dumping’ effect observed with other oral controlled-release technologies.
Geminex®
Geminex is a bilayer tablet system that allows the creation of a single tablet
with two different release profiles. It is suited for the development of products in which two-drug combinations can improve patient compliance, or where they can result in unique indications and patents.
SyncroDose™
SyncroDose is designed to release drug after a preprogrammed period of time. It can be used for the treatment of diseases of the large intestine, such as ulcerative colitis and Crohn’s Disease. In one application, Penwest developed a SyncroDose formulation of a medication for the treatment of morning stiffness caused by arthritis. This product is dosed at bedtime, and the drug is released during the overnight hours. By the time the patient wakes up, morning stiffness has been substantially reduced.
GastroDose™
Gastrodose is retained in
the stomach for extended periods of time. This approach is used for the treatment of disorders of the stomach or upper gastrointestinal tract. It is also suited for drugs that are readily absorbed into the circulation from the stomach or upper small intestine.
Why Penwest?
Oral controlled-release technologies such as TIMERx can help solve problems that emerge during formulation development. For example, small molecules are becoming increasingly difficult to formulate because of low solubility, low permeability, or both. Flexible systems such as TIMERx can incorporate other ingredients to address these challenges.
These technologies can also be used to convert injectable drugs into oral medications, as is being done with a pain medication currently in clinical development. Penwest Pharmaceuticals has the technologies and experience to craft novel oral controlled-release products.
Company profile
Penwest Pharmaceuticals is a speciality pharmaceutical company focused on the development and commercialisation of therapies for the treatment of neurological disorders. Its oral controlled release technologies are also available for the development and commercialisation of products in multiple therapeutic areas. Visit: www.penwest.com
|
